Prepare for a Pre-Approval Inspection
Your application is filed and a pre-approval inspection is coming. Walk the site from readiness assessment through data-integrity verification, application conformance, and the inspection itself — and see whether the outcome would be a recommendation for approval.
What a scenario is not
A scenario is a judgment exercise, not an assessment and not a compliance verdict. Finishing it evidences that you worked through it — nothing more — and the dimensions it scores are SPEQ’s, not any regulator’s.
The FDA is coming to inspect the site before your product can be approved. What you do in the weeks before — and how you behave in the room — decides whether the product gets a green light.
A pre-approval inspection (PAI) tests four things (FDA CP 7346.832): is the site ready to manufacture commercially, does practice conform to what the application says, is the data supporting the application trustworthy, and is there genuine commitment to quality in development. Each choice here carries forward to the outcome.
A PAI is where the application meets reality. A data-integrity gap or a filing that does not match the floor can turn an approval into a withhold — and how the team conducts itself in the room shapes everything the inspector concludes.
You are the QA lead for a site whose product application is under review. You have been told a pre-approval inspection is likely in the coming weeks.
Nothing here is a trick. Choose what a well-run site would actually do — the situation will change based on your choice.
A PAI is coming. The site passed its last routine GMP inspection, and the team is busy.
This is a judgment exercise, not a quiz: your choices change the situation. It is scored across preparation · evidence · candor · ownership — the same dimensions an inspector effectively weighs when they follow the thread of a real deviation. There is no compliance verdict here; the debriefs explain consequences.
Finishing this exercise is recorded. What it evidences — and the things it does not — is set out against the published standard.
What this evidences →